On February 22, the U.S. Food and Drug Administration (FDA) expanded the existing indication for lenalidomide (Revlimid) 10-mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant.

Clinical Trial Findings

The approval was based on two large studies—CALGB 100104 and IFM 2005-02—including more than 1,000 patients comparing lenalidomide maintenance therapy given until disease progression or unacceptable toxicity after autologous hematopoietic stem cell transplant vs no maintenance. In both studies, the primary efficacy endpoint was progression-free survival.